Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-27 @ 11:40 PM
Study NCT ID:
NCT01698060
Status:
COMPLETED
Last Update Posted:
2014-12-10
First Post:
2012-09-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunogenicity of ND1.1 by Delivery Directly to the Ileum
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005585', 'term': 'Influenza in Birds'}], 'ancestors': [{'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001715', 'term': 'Bird Diseases'}, {'id': 'D000820', 'term': 'Animal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-08', 'studyFirstSubmitDate': '2012-09-29', 'studyFirstSubmitQcDate': '2012-10-01', 'lastUpdatePostDateStruct': {'date': '2014-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety', 'timeFrame': '1 year', 'description': 'Frequency and magnitude of adverse events'}], 'secondaryOutcomes': [{'measure': 'Immunogenicity', 'timeFrame': '1 year', 'description': 'Antibody and T cell responses to HA'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Prevention of Avian Influenza'], 'conditions': ['Avian Influenza']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine the safety and tolerability of ND1.1, an adjuvanted adenoviral-based avian influenza vaccine, when delivery is targeted to the ileum, using a radio controlled capsule. The secondary objective is to evaluate the immune response (cellular and humoral) of two doses of ND1.1 oral vaccine.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able and willing to complete informed consent\n* Healthy, as established by medical history, physical exam, and laboratory assessments\n* Has normal bowel movements\n* Willing to abstain from caffeine and xanthine containing substances for 24 hours before procedure until after discharge\n\nExclusion Criteria:\n\n* Ability to donate up to 550 ml of blood over several months\n* Exposure to any investigational drug or vaccine 8 weeks prior to study\n* Has traveled to Asia within 8 weeks of enrollment\n* Abnormal ECG findings\n* History of irritable bowl or any other inflammatory gastrointestinal disorder\n* Any individual with increased risk for bowl obstruction\n* Radiation exposure above target values 50 mSv within the past 30 days or a cumulative dose above 150 mSv in the past 12 months\n* History of substance abuse\n* Subject unwilling to use an approved method of contraception during study and for 2 months after study\n* Positive for HCV, HIV, or HBV\n* Presence of an implantable device that is sensitive to radio frequencies (e.g. pacemakers)\n* History of an autoimmune disorder, or an immunosuppressive disorder\n* Stool sample with occult blood at baseline\n* Any other medical, psychiatric, social condition, or occupation, in the judgement of the investigator, is a contraindication to the compliance of the protocol or informed consent'}, 'identificationModule': {'nctId': 'NCT01698060', 'acronym': 'ICC H5', 'briefTitle': 'Immunogenicity of ND1.1 by Delivery Directly to the Ileum', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vaxart'}, 'officialTitle': 'An Open Label Phase I Substudy to Evaluate the Safety and Ability to Enhance Immunogenicity of ND1.1 by Delivery Directly to the Ileum Using the InteliSite® Companion Capsule in Healthy Adult Males', 'orgStudyIdInfo': {'id': 'VXA01-001subA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intestinal Delivery', 'description': 'ND1.1', 'interventionNames': ['Biological: ND1.1']}], 'interventions': [{'name': 'ND1.1', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Intestinal Delivery']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Scintipharma', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}], 'overallOfficials': [{'name': 'David Liebowitz, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Vaxart, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vaxart', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}